Who is the manufacturer of DALL-MILES TROCHANTER CABLE SUPERGRIP?

Howmedica Corp. filed the 510(k) submission for DALL-MILES TROCHANTER CABLE SUPERGRIP (K962162).

What is the FDA product code for DALL-MILES TROCHANTER CABLE SUPERGRIP?

JDQ. It is classified under 21 CFR 888.3010 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DALL-MILES TROCHANTER CABLE SUPERGRIP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DALL-MILES TROCHANTER CABLE SUPERGRIP?

Dall-Miles Cable Grip System (K872224); Dall-Miles Cable Grip System (K900926); Biomet Medical Products' BMP Cable System.

Who can help prepare an FDA 510(k) submission like DALL-MILES TROCHANTER CABLE SUPERGRIP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DALL-MILES TROCHANTER CABLE SUPERGRIP

K962162 · Howmedica Corp. · JDQ · Aug 14, 1996 · Orthopedic

Device Facts

Record ID	K962162
Device Name	DALL-MILES TROCHANTER CABLE SUPERGRIP
Applicant	Howmedica Corp.
Product Code	JDQ · Orthopedic
Decision Date	Aug 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3010
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place.

Device Story

Bone fixation cerclage system; used for trochanteric reattachment post-osteotomy in total hip arthroplasty. Device consists of a grip component with proximal hooks and cables. Hooks placed over trochanter; cables passed through grip holes and crimped to secure. Modification reduces cable exit angle to minimize stress concentrations. Used by orthopedic surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Bone fixation cerclage; metallic grip component with cable-based tensioning and crimping mechanism. Design modification reduces cable exit angle to mitigate stress concentrations. Sterilization and material specifications not explicitly detailed in summary.

Indications for Use

Indicated for trochanteric reattachment following osteotomy in Total Hip Arthroplasty.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

Dall-Miles Cable Grip System (K872224)
Dall-Miles Cable Grip System (K900926)
Biomet Medical Products' BMP Cable System

Related Devices

K961267 — PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE · Pioneer Surgical Technology · Jun 27, 1996
K072250 — SUPERCABLE GRIP AND PLATE SYSTEM · Kinamed, Inc. · Nov 9, 2007
K043252 — CABLING SYSTEM TROCHANTER HOOK · Smith & Nephew, Inc. · Jan 14, 2005
K151907 — Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables · Zimmer, Inc. · Dec 30, 2015
K980594 — OSTEONICS FX-CABLELOK GRIP COMPONENTS · Osteonics Corp. · May 5, 1998

Submission Summary (Full Text)

{0} AUG 14 1996 K96 216 2 510(k) Summary Proprietary Name: Dall-Miles Trochanter Cable SuperGrip Common Name: Bone Fixation Cerclage Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010 Proposed Regulatory Class: Class II Device Product Code: OR(87) JDQ For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 6/3/96 The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place. The modification to the Grip reduces the angle that the cable exits the Grip, thereby relieving potential stress concentrations in the cable. The substantial equivalence of the Dall-Miles Trochanter Cable Grip is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's original Dall-Miles Cable Grip System (K 872224 and K 900926) and Biomet Medical Products' BMP Cable System.